Doug Kelly, MD and U.S. FDA Chief Scientist, Center for Devices and Radiological Health, will deliver the lunch keynote on Thursday, May 26th, 2022 at Southeast Life Science’s AdvanSE 2022. As a leader in the FDA’s transformation to integrate innovators, payors, and regulatory agencies to more rapidly enable innovators to improve patient care and lower healthcare costs, Dr. Kelly will discuss FDA’s new Total Life Cycle Advisory Program
Dr. Kelly joined the FDA in 2020 after a 30-year career in the life sciences venture capital companies spanning biotech, medical devices, robotics, laboratory tools, healthcare IT, ADME/Tox simulation and clinical trial software. At CDRH, Dr.Kelly is the interface between the FDA and patient and physician groups, payors, industry, academia, innovators, investors, and other agencies and governments. His focus is on creating a more vibrant and sustainable medtech ecosystem, to bring new innovations to patients faster to relieve suffering, especially in unserved and underserved populations.
At his lunchtime keynote on Thursday, Dr. Kelly will present information about the new FDA’s Total Life Cycle Advisory Program (TAP) for Breakthrough-Designated products. The program combines early stakeholder input, strategic advisory services, real-time communications and radical transparency to dramatically reduce the risk, time and cost of early-stage medtech while producing more financially sustainable companies and better characterized, safer and more effective products.
Dr. Kelly will be our guest for his presentation, as well as participant in the conference, allowing AdvanSE company executives to explore how the FDA is working with payers and others to ensure that innovations are not only cleared by the regulatory agency, but also how to present patient-centered cost effectiveness data to provide CMS payment coverage.
As a former VC himself, Kelly is eager to meet with the Southeast’s top investors to see what companies are emerging and how he might help interpret the new breakthrough pathway especially around information-technology driven medical devices including machine-learning and hospital-at-home platforms.
Doug received his BA in Biochemistry and Cell Biology with honors from University of California, San Diego, his MD from the Albert Einstein College of Medicine, and his MBA at the Stanford University Graduate School of Business. In addition to lecturing at the Stanford GSB and Medical School, he conceived of and taught the class “Financing The Start-up,” for over a decade the Stanford’s Department of Continuing Education biggest and most popular class.
“Doug’s extensive experience on multiple sides of the life science innovation spectrum as an investor, an innovator and a regulator makes his keynote and multi-day attendance at AdvanSE 2022 reason enough in itself for those that work in the ecosystem to attend,” said Southeast Life Science Board Member and HealthQuest Capital Venture Partner Tom Callaway, MD.
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